Cleared Traditional

K902060 - ESCORT MODEL 300

K902060 is an FDA 510(k) clearance for ESCORT MODEL 300, manufactured by Medical Data Electronics. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K902060 · Medical Data Electronics · Anesthesiology device
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Jun 1990
Decision
35d
Days
Class 2
Risk

K902060 is an FDA 510(k) clearance for the ESCORT MODEL 300. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on June 11, 1990 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Data Electronics devices

FDA 510(k) Submission Details - K902060

510(k) Number K902060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date June 11, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K902060.
ITC ANGIOGRAPHIC CATHETER
K900757 · Interventional Therapeutics Corp. · Aug 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
K901774 · Mennen Medical, Inc. · May 1990
OXYTRAK(TM) PULSE OXIMETER
K894100 · Critikon Company, LLC · May 1990
MODEL 90489 PULSE OXIMETER MODULE
K901209 · Spacelabs, Inc. · Apr 1990